BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RANDOX CARBAMAZEPINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HI-TORQUE WINN GUIDE WIRE FAMILY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013

    POLYHESIVE PATIENT RETURN ELECTRODE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·June 2, 2011

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 13, 2008

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·November 28, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021